In the field of automatic pharmaceutical and prescription dispensing, specifically in mail order and central fill applications, the facility is larger and the multiple steps to dispensing are spread out in space, time, and across more persons, than in a retail application. A closed and sealed system is preferred to transport drugs from a filling area to the dispenser. Since dispensers, canisters, or containers are not open, the opportunity for contamination is eliminated and the level of inventory control is increased. Removable, refillable canisters have been used to fulfill this function. These first canisters were nothing more than simple, box-like containers that mated with automatic pill-counting dispensers. As dispensing systems became more sophisticated, the price of medications increased, human error increased, malefactors proliferated, and the potency and contra-indications of the pharmaceuticals increased in quantity and severity. It has become clear that the original canisters lacked the safety and control that are needed and often legally required.
United States Published Patent Application No. 2006/0184271 for CARTRIDGE-LOADED AUTOMATIC PRESCRIPTION PILL DISPENSING SYSTEM AND DISPENSING UNIT AND CARTRIDGE FOR USE THEREIN, filed by Calvin J. Loveless on Nov. 23, 2005 and published on Aug. 17, 2006, discloses an automatic prescription pill dispensing unit that uses a cartridge in which prescription drugs are pre-loaded, preferably by a pharmacist, according to the user's medication regimen. This tamper-proof cartridge can be unlocked only by a pharmacist using a specially designed loading dock, or by inserting the cartridge into the user's dispensing unit.
U.S. Pat. No. 6,988,634 for CARTRIDGE FOR DISPENSING PILL OR CAPSULE-FORM MEDICATIONS IN DESIRED DOSES, issued to Reijo Varis on Jan. 24, 2006, discloses a dispensing device that includes a cartridge rotatable relative to a housing or frame and provided with discrete dosage compartments for desired doses of medication. Each separate dosage compartment of the cartridge is rotatable relative to the housing or frame to a dispensing point for the dose of medication. A signaling device producing a sound and/or light signal activates at pre-programmed times. An electronics unit contains a reprogrammable dispensing program. The cartridge is adapted to be disengaged from the dispensing device and to be transferred to a loading device, which fills the dosage compartments of the cartridge with desired doses of medication and furnishes the filled cartridge with identification data.
U.S. Pat. No. 6,119,892 for MODULAR POCKET MEDICATION DISPENSER, issued to Nerve Laurent et al. on Sep. 19, 2000, discloses a modular medication dispenser adapted to be held in a pocket and composed of two compartments containing electronics sufficient for memory, calculation and data retrieval relating to medication dispensing by a compartment. The main module also comprises visual data displays and alarms. At least one detachable additional compartment, comprising locking means and fasteners and forming a storage space for a given type of tablets, is detachably attached to the main module. The locking means and the fasteners of the preceding compartment cooperate with the fasteners and locking means of the next additional compartment. Each compartment comprises a drive means for a unit-dispensing component adaptable to different sizes of pharmaceutical medications.
U.S. Pat. No. 6,102,855 for VARIABLE CAPACITY MEDICATION CONTAINER AND LABELING SYSTEM FOR MEDICAL MONITORING DEVICE, issued to Bruce A. Kehr on Aug. 15, 2000, discloses a medical monitoring device, operating system, and method for managing administration of medical treatment regimens. The device stores medication schedule data, treatment data, patient query data, and patient response data. The device includes a controller for controlling modes of operation of the device, controlling access of the memory, controlling display of the treatment data and the patient query data on a display, receiving and processing patient response data, tracking timing, and providing scheduled medication alarm signals. The device provides scheduled medication alarm signals that alert the user concerning prescribed medications due to be taken. The device further includes removable trays of varying capacities.
U.S. Pat. No. 2,493,616, issued to Alexander Burns on Jan. 3, 1950, discloses a container carried by an individual for medicinal tablets.
These patents describe devices that are targeted for single or at most a couple of medications for a single user. They have differing levels of sophistication with features such as timers, alarms, locks, recording devices, data collection, etc. They have compartments to store medications for a day, week or perhaps longer. Some are filled by the user, some by a caregiver or pharmacist. These are end user devices, and do not describe solutions to the needs of centralized dispensing of thousands of prescriptions for thousands of persons.
Many facilities fill thousands of prescriptions for many customers, but they commonly have dispensing machines which have very limited capacity. The drugs that are most commonly prescribed require many replenishment routines per day to avoid running out of product. These refilling routines are a weak point in this process on two counts. First, it is a source of filling error. While bar codes have improved accuracy, there is still an element of human nature to shortcut established routines that are monotonous or tedious. An example would be where the replenishment of a dispenser requires a dozen small stock bottles. Rather than scanning each individual bottle, one bottle is scanned twelve times. One of the eleven bottles not scanned could be the right drug but the wrong dosage.
The second vulnerability is a source of inventory error, where the filling person scans a bottle of 2000 tablets but does not pour the whole bottle into the dispenser, or where a few tablets could be removed, thereby making the recorded inventory differ from the actual inventory.
What is needed in mail order/central fill applications is a design and a method to securely transport drug product from a secure filling area, under the supervision of a pharmacist, to the many dispensers on the production floor. A design should allow technicians, not a pharmacist, to perform the dispenser replenishment. This transport means should have a capacity of at least one dispenser-full, but could be several or many times the normal capacity of the dispenser.
The method should be closed, and at no time should product be exposed to possible contamination, spillage, or pilferage. The method should have a strict, rigid protocol that eliminates errors. The protocol should include as few steps as possible to prevent the impetus or motivation to skip steps.
To the extent possible, the dispenser and canister should automatically enhance the security of replenishment and actively prevent product mismatches, eliminating errors before they occur.
The general requirements for canister replenishment should include:
a) dispenser automatically closed and locked when canister removed;
b) canister automatically closed and locked when removed from dispenser or docking station;
c) canister sealed by pharmacist after filling and verifying;
d) canister automatically locked onto dispenser while in place;
e) safety systems in place in robotic applications so multiple, adjacent canisters can be removed for group replenishment;
f) illuminated indicator(s) visible to replenishment person for status;
g) clear top-filling access door so contents can be seen;
h) canister upright in docking station for re-filling;
i) canister sealed by pharmacist after filling and verifying;
j) seal not necessarily broken to install/dispense;
k) seal removed prior to next filling of canister;
l) canisters optionally of different sizes (capacities);
m) canister having electronics on-board;
n) canister adapted to “meter” product into dispenser:                controlled rate of dump (regulated door)        controlled quantity of dump (sections or partitions); and        
o) canister having external bar code and serial number.
It would be advantageous for a canister to be filled or at least verified by a registered pharmacist and then sealed, and then carried to the location of a dispenser and attached thereto by another person of lesser skill (and lower cost to the facility), such operations being performed so that neither the contents of the canister nor the contents of the dispenser can be accessed by the person who attaches the canister to the dispenser.
It would be advantageous for the canister to house electronics that contains information about the identity of the pharmaceutical, and that can communicate with similar electronics in the dispenser, in order to assure that the correct drug canister is being attached.
It would also be advantageous for the canister to have sensors to detect if the canister filling door has been compromised at any time away from the docking station, even when it is not connected to the dispenser. To alert the control system that a compromise has occurred and that the canister has to be returned to the pharmacist for re-verifying and a possible inventory check.